FDA Adverse Event Death Summary report: N

SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM

MDR report key: 4276787 · Received November 18, 2014

Report

Report Number
9681138-2014-00050
Event Type
Death
Date Received
November 18, 2014
Report Date
November 11, 2014
Manufacturer
GSK DUNGARVAN STAFFORD MILLER
Product Code
KOL
Report Source
Manufacturer report
Reporter Location
US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

ALZHEIMERS [ALZHEIMER'S DISEASE]. DEMENTIA [DEMENTIA]. HOSPITALIZATION FOR UNK REASON [HOSPITALIZATION]. BROKE HIS HIPS [FRACTURED HIP]. FALL [FALL]. WHEELCHAIR USER [WHEELCHAIR USER]. DRUG MALADMINISTRATION [DRUG MALADMINISTRATION]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF ALZHEIMERS IN A MALE PT WHO RECEIVED TRIPLE SALT DENTAL ADHESIVE CREAM (SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM) UNK FOR AN UNK INDICATION. ON AN UNK DATE, THE PT STARTED SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM. ON AN UNK DATE, AN UNK TIME AFTER STARTING SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM, THE PT EXPERIENCED ALZHEIMERS (SERIOUS CRITERIA DEATH AND GSK MEDICALLY SIGNIFICANT), AND GSK MEDICALLY SIGNIFICANT), HOSPITALIZATION FOR UNK REASON (SERIOUS CRITERIA HOSPITALIZATION AND GSK MEDICALLY SIGNIFICANT), BROKE HIS HIPS (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), FALL, WHEELCHAIR USER AND DRUG MALADMINISTRATION. SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM WAS DISCONTINUED. ON AN UNK DATE, THE OUTCOME OF THE ALZHEIMERS AND DEMENTIA WERE FATAL AND THE OUTCOME OF THE HOSPITALIZATION FOR UNK REASON, BROKE HIS HIPS, WHEELCHAIR USER AND DRUG MALADMINISTRATION WERE UNK AND THE OUTCOME OF THE FALL WAS RECOVERED/RESOLVED. THE PT DIED IN 2013. THE REPORTED CAUSE OF DEATH WAS ALZHEIMER'S DISEASE, DEMENTIA AND DEATH FROM NATURAL CAUSES. THE REPORTER CONSIDERED THE ALZHEIMERS AND DEMENTIA TO BE RELATED TO SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM. IT WAS UNK IF THE REPORTER CONSIDERED THE HOSPITALIZATION FOR UNK REASON, BROKE HIS HIPS, FALL AND WHEELCHAIR USER TO BE RELATED TO SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM. ADDITIONAL DETAILS: THE PT'S SON CALLED AND REPORTED THAT DUE TO HIS FATHER USING SUPER POLIGRIP ORIGINAL WITH ZINC YEARS PRIOR, IT CAUSED HIM TO DEVELOP ALZHEIMER'S AND DEMENTIA. THE CONSUMER'S SON REPORTED THAT HIS FATHER DIED FROM DEMENTIA APPROXIMATELY A YEAR PRIOR TO THIS REPORT, BUT HE DID NOT FEEL THE DEATH WAS CAUSED BY SUPER POLIGRIP BUT FROM NATURAL CAUSES. THE CONSUMER'S SON REPORTED THAT HIS FATHER WAS IN THE HOSPITAL FOR APPROXIMATELY 4 TO 5 YEARS PRIOR TO HIS DEATH. THE CONSUMER'S SON ADDITIONALLY REPORTED DRUG MALADMINISTRATION WHICH HE FURTHER DESCRIBED AS HIS FATHER CONTINUALLY PULLING HIS DENTURES IN AND OUT OF HIS MOUTH AND REAPPLYING SUPER POLIGRIP MANY TIMES. THE REPORTER ALSO REPORTED THAT HE HAD SIMILAR EVENT, SEE CAUSE (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
745236 SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM DENTURE ADHESIVE KOL GSK DUNGARVAN STAFFORD MILLER

Patients

Seq Age Sex Outcome Treatment
1 Death